DiabetesDIAB-PDNCT07788235
Diabetes and Permanent Disabilities
An observational study of Diabetes and Diabetes (Insulin-requiring, Type 1 or Type 2), run by Assuta Medical Center at 2 sites in Israel.
Trial summary
This study examines permanent disability related to diabetes using routinely collected data from the National Insurance Institute of Israel. The study will evaluate how often diabetes is recorded among people who have been granted permanent disability and whether the frequency and severity of diabetes-related… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes (Insulin-requiring, Type 1 or Type 2)
- How many people
- 450,000 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jan 2018to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Temporary disability determinations without recognition of permanent disability. Records outside the predefined study period. Records with insufficient or incomplete information for classification of diabetes-related disability or geographic district. Duplicate administrative records, when identified.
Who may be able to join
- Individuals with a permanent disability determination recorded by the National Insurance Institute of Israel between January 1, 2020 and December 31, 2025.
- Records containing sufficient information to determine whether diabetes mellitus contributed to the permanent disability assessment.
- For diabetes-specific analyses, individuals with diabetes mellitus documented as a recognized condition contributing to permanent disability.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Assuta Medical Center
Rishon LeZiyyon, 7526557
Israel National Insurance Institute
Rishon LeZiyyon, 7526557
About this study
Official title: Diabetes and Permanent Disability: Geographic and Temporal Patterns, 2020-2025 (DIAB-PD)
This study examines permanent disability related to diabetes using routinely collected data from the National Insurance Institute of Israel.
The study will evaluate how often diabetes is recorded among people who have been granted permanent disability and whether the frequency and severity of diabetes-related disability differ by geographic area and over time. It will also examine the distribution of disability according to the statutory level of diabetes-related impairment.
Read more
Data from 2020 through 2025 will be analyzed. The study is observational and retrospective, meaning that it uses information that has already been collected for administrative purposes. No participants will receive an intervention, medication, or additional medical examination as part of the study.
The main goals are to describe national and regional patterns of diabetes-related permanent disability, identify changes over time, and determine whether meaningful geographic differences exist. The findings may help improve understanding of the burden of diabetes-related disability and support future health care, prevention, rehabilitation, and social-policy planning.
Read the detailed description
This retrospective observational study will evaluate the burden and distribution of diabetes-related permanent disability using administrative records from the National Insurance Institute of Israel for the years 2020-2025.
The analysis will include individuals with recognized permanent disability and will identify records in which diabetes is included among the conditions contributing to the disability determination. Diabetes-related disability will be characterized according to the statutory impairment categories used by the National Insurance Institute. Geographic variation will be examined across the major administrative districts, together with changes in the number and proportion of diabetes-related disability records over time.
The study will assess temporal and regional patterns in diabetes-related permanent disability and explore whether the distribution of disability severity differs between geographic areas or study years. Where appropriate, rates, proportions, comparative measures, and statistical tests of geographic and temporal heterogeneity will be used to describe these differences.
Because the study is based exclusively on previously collected administrative data, participants will not undergo additional examinations, interventions, or changes in medical care. The study is intended to provide population-level evidence regarding the social and disability burden associated with diabetes and to identify geographic or temporal differences that may be relevant to prevention strategies, health-service planning, rehabilitation, and disability policy.
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes and co-morbidities | All individuals with a recognized permanent disability recorded by the National Insurance Institute of Israel between 2020 and 2025 will constitute the study population. Within this population, records in which diabetes mellitus is documented as a condition contributing to the permanent disability determination will be identified and analyzed. Diabetes-related disability will be classified according to the applicable statutory impairment categories. Geographic and temporal patterns will be evaluated across administrative districts and study years. This is a retrospective observational study based on routinely collected administrative data; no intervention, treatment, or additional clinical assessment will be performed as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes co-morbidities
Proportion of permanent-disability records in which diabetes mellitus is recognized as a condition contributing to the permanent disability determination, overall and by geographic district.
Measured: 8 years
Secondary outcomes (1)
diabetes-related permanent disability severity
Distribution of diabetes-related permanent disability according to statutory diabetes impairment categories, compared across geographic districts and calendar years.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jan 2018
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 450,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788235
- Sponsor's protocol ID
- BTL0001-2026
- Acronym
- DIAB-PD
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is based on administrative records provided by the National Insurance Institute of Israel under institutional, ethical, and data-protection restrictions. The investigators are not authorized to distribute individual-level data to third parties. Aggregated, non-identifiable study results may be reported in publications and scientific presentations.
Publications
Herquelot E, Gueguen A, Bonenfant S, Dray-Spira R. Impact of diabetes on work cessation: data from the GAZEL cohort study. Diabetes Care. 2011 Jun;34(6):1344-9. doi: 10.2337/dc10-2225. Epub 2011 May 11.
PubMed 21562323Nexo MA, Pedersen J, Cleal B, Bjorner JB. Increased risk of long-term sickness absence, lower rate of return to work and higher risk of disability pension among people with type 1 and type 2 diabetes mellitus: a Danish retrospective cohort study with up to 17 years' follow-up. Diabet Med. 2020 Nov;37(11):1861-1865. doi: 10.1111/dme.14203. Epub 2019 Dec 17.
PubMed 31811666Ervasti J, Virtanen M, Pentti J, Lallukka T, Tinghog P, Kjeldgard L, Mittendorfer-Rutz E, Alexanderson K. Work disability before and after diabetes diagnosis: a nationwide population-based register study in Sweden. Am J Public Health. 2015 Jun;105(6):e22-9. doi: 10.2105/AJPH.2015.302646. Epub 2015 Apr 16.
PubMed 25879142Breton MC, Guenette L, Amiche MA, Kayibanda JF, Gregoire JP, Moisan J. Burden of diabetes on the ability to work: a systematic review. Diabetes Care. 2013 Mar;36(3):740-9. doi: 10.2337/dc12-0354. No abstract available.
PubMed 23431092Wong E, Backholer K, Gearon E, Harding J, Freak-Poli R, Stevenson C, Peeters A. Diabetes and risk of physical disability in adults: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2013 Oct;1(2):106-14. doi: 10.1016/S2213-8587(13)70046-9. Epub 2013 Jul 24.
PubMed 24622316
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes and Permanent Disability: Geographic and Temporal Patterns, 2020-2025 (DIAB-PD)
- ClinicalTrials.gov ID
- NCT07788235
- Acronym / sponsor ID
- DIAB-PD / BTL0001-2026
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450,000 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines permanent disability related to diabetes using routinely collected data from the National Insurance Institute of Israel.
The study will evaluate how often diabetes is recorded among people who have been granted permanent disability and whether the frequency and severity of diabetes-related disability differ by geographic area and over time. It will also examine the distribution of disability according to the statutory level of diabetes-related impairment.
Data from 2020 through 2025 will be analyzed. The study is observational and retrospective, meaning that it uses information that has already been collected for administrative purposes. No participants will receive an intervention, medication, or additional medical examination as part of the study.
The main goals are to describe national and regional patterns of diabetes-related permanent disability, identify changes over time, and determine whether meaningful geographic differences exist. The findings may help improve understanding of the burden of diabetes-related disability and support future health care, prevention, rehabilitation, and social-policy planning.
Detailed description
This retrospective observational study will evaluate the burden and distribution of diabetes-related permanent disability using administrative records from the National Insurance Institute of Israel for the years 2020-2025.
The analysis will include individuals with recognized permanent disability and will identify records in which diabetes is included among the conditions contributing to the disability determination. Diabetes-related disability will be characterized according to the statutory impairment categories used by the National Insurance Institute. Geographic variation will be examined across the major administrative districts, together with changes in the number and proportion of diabetes-related disability records over time.
The study will assess temporal and regional patterns in diabetes-related permanent disability and explore whether the distribution of disability severity differs between geographic areas or study years. Where appropriate, rates, proportions, comparative measures, and statistical tests of geographic and temporal heterogeneity will be used to describe these differences.
Because the study is based exclusively on previously collected administrative data, participants will not undergo additional examinations, interventions, or changes in medical care. The study is intended to provide population-level evidence regarding the social and disability burden associated with diabetes and to identify geographic or temporal differences that may be relevant to prevention strategies, health-service planning, rehabilitation, and disability policy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes and co-morbidities | – | –All individuals with a recognized permanent disability recorded by the National Insurance Institute of Israel between 2020 and 2025 will constitute the study population. Within this population, records in which diabetes mellitus is documented as a condition contributing to the permanent disability determination will be identified and analyzed. Diabetes-related disability will be classified according to the applicable statutory impairment categories. Geographic and temporal patterns will be evaluated across administrative districts and study years. This is a retrospective observational study based on routinely collected administrative data; no intervention, treatment, or additional clinical assessment will be performed as part of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Temporary disability determinations without recognition of permanent disability. Records outside the predefined study period. Records with insufficient or incomplete information for classification of diabetes-related disability or geographic district. Duplicate administrative records, when identified.
Key inclusion criteria (3 listed)
- Individuals with a permanent disability determination recorded by the National Insurance Institute of Israel between January 1, 2020 and December 31, 2025.
- Records containing sufficient information to determine whether diabetes mellitus contributed to the permanent disability assessment.
- For diabetes-specific analyses, individuals with diabetes mellitus documented as a recognized condition contributing to permanent disability.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetes co-morbidities
Time frame: 8 years
Proportion of permanent-disability records in which diabetes mellitus is recognized as a condition contributing to the permanent disability determination, overall and by geographic district.
1 secondary outcome
diabetes-related permanent disability severity
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 21562323Herquelot E, Gueguen A, Bonenfant S, Dray-Spira R. Impact of diabetes on work cessation: data from the GAZEL cohort study. Diabetes Care. 2011 Jun;34(6):1344-9. doi: 10.2337/dc10-2225. Epub 2011 May 11.
- Background: PubMed 31811666Nexo MA, Pedersen J, Cleal B, Bjorner JB. Increased risk of long-term sickness absence, lower rate of return to work and higher risk of disability pension among people with type 1 and type 2 diabetes mellitus: a Danish retrospective cohort study with up to 17 years' follow-up. Diabet Med. 2020 Nov;37(11):1861-1865. doi: 10.1111/dme.14203. Epub 2019 Dec 17.
- Background: PubMed 25879142Ervasti J, Virtanen M, Pentti J, Lallukka T, Tinghog P, Kjeldgard L, Mittendorfer-Rutz E, Alexanderson K. Work disability before and after diabetes diagnosis: a nationwide population-based register study in Sweden. Am J Public Health. 2015 Jun;105(6):e22-9. doi: 10.2105/AJPH.2015.302646. Epub 2015 Apr 16.
- Background: PubMed 23431092Breton MC, Guenette L, Amiche MA, Kayibanda JF, Gregoire JP, Moisan J. Burden of diabetes on the ability to work: a systematic review. Diabetes Care. 2013 Mar;36(3):740-9. doi: 10.2337/dc12-0354. No abstract available.
- Background: PubMed 24622316Wong E, Backholer K, Gearon E, Harding J, Freak-Poli R, Stevenson C, Peeters A. Diabetes and risk of physical disability in adults: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2013 Oct;1(2):106-14. doi: 10.1016/S2213-8587(13)70046-9. Epub 2013 Jul 24.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is based on administrative records provided by the National Insurance Institute of Israel under institutional, ethical, and data-protection restrictions. The investigators are not authorized to distribute individual-level data to third parties. Aggregated, non-identifiable study results may be reported in publications and scientific presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes (Insulin-requiring, Type 1 or Type 2), run by Assuta Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes co-morbidities (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788235, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.